| TGA Action ID |
RC-2026-RN-00338-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Ion Endoluminal System - Vision Probe Bag
Part Number: 490127
Batch Number: DM01254324 |
| ARTG Number |
471706 |
| Unique Device Identifier (UDI) |
00886874119594 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
In January 2026, Device Technologies issued an Urgent Recall (TGA Reference: RC-2026-RN-00012-1) for specific lot numbers of the Vision Probe Bag due to a sterile pouch seal integrity problem. The scope of the recall has since been expanded to include one additional batch.
Some Vision Probe Bags used with the Ion Endoluminal System may have compromised or incomplete sterile pouch seals. This problem may occur if air becomes trapped within the pouch during manufacturing and sterilisation, potentially resulting in partial seal failure and a loss of sterility.
The problem was identified through internal quality processes, and no complaints have been reported to date. |
| Instructions for Customers/Users |
Customers are to:
- Inspect the product pouch seal of all devices with the affected batch number
- Not use any product where the seal is compromised or incomplete, and dispose of affected units in accordance with their facility’s disposal procedures. |
| Action Commencement Date |
5/05/2026 |
| Responsible Entity |
|
| Contact Information |
1300 338 423 - Device Technologies |